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 Click here for Select Course Listing |
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| FDA Inspections |
| E-4. FDA Organization, Inspection Authority and Inspection Procedures |
- FDA Field Office Responsibilities
- FDA Investigator Training and Qualifications
- FDA Inspection Authority and Jurisdiction
- FDA Inspection Program
- FDA Procedures, Tactics and Follow-up
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Level: A
Approx. Time: 75 min. |
| E-7. Preparation for and Handling FDA Inspections |
- Establishment of Company Policy and Procedures
- Logistics and Document Organization
- Personnel Training
- FDA Escort Team Qualifications
- Escort’s Handling of Inspection and Responsibilities
- Discussion with Management (Exit Interview)
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Level: A
Approx. Time: 75 min. |
| E-8. FDA Inspections: Dos and Don'ts |
- Basic Inspection Behaviors
- Answering Questions
- Reviewing Records with the Investigator
- Volunteering Information
- Recommendations
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Level: B
Approx. Time: 60 min. |
| E-10. Preparation for an FDA Pre-Approval Inspection |
- FDA Pre-approval Inspection Program
- Preparation for the PAI
- Preparation for the PAI: Organization and Strategy
- Handling the PAI Inspection
- DOs and DON’Ts for the PAI
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Level: A
Approx. Time: 60 min. |
| E-12. International Inspections |
- FDA Organization and Field Office Roles
- FDA Inspection Guidance and Manuals
- Inspection Authority, Procedures and Coverage
- FDA Forms, Sample/Records Collections
- Discussion with Management
- Inspection Report
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Level: A
Approx. Time: 75 min. |
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